Drug-Coated Balloons for the Treatment of Symptomatic Intracranial High-Grade Stenosis: A Review of the Current Rationale

Abstract

Symptomatic intracranial atherosclerotic disease (sICAD) remains a challenging disorder in the neurovascular field. Despite best medical treatment, the recurrence rate for stroke remains high in patients with intracranial high-grade stenosis (>70–99%). Furthermore, two large randomized trials (SAMMPRIS and VISSIT) failed to prove the efficacy of percutaneous transluminal angioplasty and stenting in patients with sICAD. Drug-coated balloon percutaneous transluminal angioplasty (DCB-PTA) represents an alternative treatment modality with therapeutic benefits for interventional cardiology. However, there are very few articles in the existing literature that relate to the use of DCB-PTA in sICAD patients. Here, we aimed to review the rationale underlying the use of DCB-PTA in sICAD patients and summarize recent developments in the neurovascular field.

Drug-coated Balloons in the Neurovascular Setting: A Comprehensive, Systematic Review of Current Use and Indications

“…[ 46 , 47 ] with promising results and was only revisited in 2018 [ 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 ]. However, despite good results and reviews continuing to advocate for the evaluation of DCB in the treatment and prevention of ECAS and ICAS in in-stent restenosis [ 57 , 58 , 59 ] and restenosis, data addressing the use of DCB and the evaluation of its possible benefits in the neurovascular setting remain rare; consequently, we believe that this field is under-investigated, and publications are lacking.…”

A novel cerebrovascular drug-coated balloon catheter for treating symptomatic intracranial atherosclerotic stenosis lesions: Study protocol for a prospective, multicenter, single-arm, target-value clinical trial

“…The rationale for using a single-arm trial design was that there is currently a lack of industry evaluation standards for the safety and effectiveness of intracranial DCB; however, intracranial DCB therapy is a relatively mature treatment method. 15 , 16 In addition, the inclusion standard of diseased arteries in this study was set at ​≥ ​l mm, and there are no other proven safe and effective products to serve as controls; as such, we decided to use the single-arm, target-value method for evaluation. Based on previous literature reports addressing intracranial drug balloons and clinical experience, we estimated the restenosis rate within 6 months and ultimately decided to include 155 subjects.…”